Antibody Contract Manufacturing Market

Market Overview

The global antibody contract manufacturing market size was valued at USD 7.5 billion in 2023 and is projected to reach USD 22.0 billion by 2032, registering a CAGR of 12.6% during the forecast period (2024-2032). Biopharmaceuticals, diagnostics, and research applications drive the growth of antibody contract manufacturing.

Antibody contract manufacturing is outsourcing antibody production to specialist contract development and manufacturing organizations (CDMOs) or contract manufacturing organizations (CMOs). These firms provide expertise, facilities, and resources for antibody research, manufacture, and purification on behalf of biotech and pharmaceutical corporations.

The global antibody contract manufacturing market is expanding rapidly, driven by rising demand for monoclonal antibodies (mAbs) in pharmaceuticals, diagnostics, and research applications. Factors such as the rise in chronic diseases, technological advances in biotechnology, and the tendency to outsource among pharmaceutical and biotechnology industries drive market growth. With increased investment in R&D, tight regulatory guidelines, and rising biopharmaceutical markets in Asia-Pacific and Latin America, antibody contract manufacturing services are becoming increasingly important. 

Highlights

• Monoclonal Antibodies account for the largest share of the market based on product.
• Mammalian generates the highest revenue share by source.
• Biopharmaceutical Companies hold a significant market share by end-users.

Market Dynamics

Global Antibody Contract Manufacturing Market Drivers

Increasing Demand for Monoclonal Antibodies

Due to their great specificity and potency, monoclonal antibodies have become popular in various therapeutic fields, including oncology, autoimmune illnesses, and infectious diseases. For example, trastuzumab (Herceptin) for breast cancer and adalimumab (Humira) for autoimmune diseases have transformed therapeutic paradigms. The COVID-19 pandemic has boosted market growth potential by accelerating the development of various mAbs targeting the SARS-CoV-2 virus. Because of their safety and effectiveness, mAbs are a viable alternative for COVID-19 mitigation, and some of these antibodies have received emergency use authorizations (EUA) from the US FDA. For example, in February 2022, the United States Food and Drug Administration approved Eli Lilly's bebtelovimab for the treatment of COVID-19 individuals who are at risk of developing severe disease or who may require hospitalization. 

Furthermore, the U.S. Department of Health and Human Services announced the provision of at least 600,000 free bebtelovimab courses, with an optional purchase of 500,000 additional doses in the future, offering new chances to expand mAbs.The key benefits of mAb treatments over earlier therapies in terms of specificity, efficacy, and ease of delivery have resulted in numerous new product launches and approvals in this field. As a result, demand for contract manufacturing services for monoclonal antibodies is projected to follow this upward trend.

Thus, the growing demand for monoclonal antibodies in various therapeutic areas and the tendency to outsource among biopharmaceutical companies are significant drivers of global antibody contract manufacturing. 

Global Antibody Contract Manufacturing Market Restraints

High Initial Investment

Establishing and maintaining antibody manufacturing facilities requires significant upfront infrastructure, equipment, and technology investments. This expensive initial expenditure can be a barrier to entry for new contract manufacturing firms, discouraging smaller biopharmaceutical businesses from outsourcing antibody production. For example, the cost of producing a monoclonal antibody might range from USD 6,000 to USD 15,000, although polyclonal antibodies can be as little as USD 1,000. The cost of goods sold (COGS) for antibody-drug conjugates (ADCs) is mainly dictated by raw material costs, with the drug-linker raw material alone costing USD 200-USD 2,000 per gram.

In March 2023, Samsung Biologics plans to invest USD 1.5 billion (?1.9 trillion) in a new biomanufacturing facility in Incheon, South Korea. Plant 5 will be part of Bio Campus II and will be finished in 2032. It will have a 180,000-liter manufacturing capacity near the company's current Songdo International Business District location. 

Similarly, in May 2021, Lonza announced plans to invest USD 936 million in mammalian production facilities in Portsmouth, New Hampshire, and Visp, Switzerland. The new facilities are designed to meet client demand for capacity, speed-to-market, and life cycle management. The Visp facility will feature six 20,000L bioreactors, and the Portsmouth facility will have up to eight 2,000L bioreactors. The Visp facility will be finished in 2024 for USD 716 million. 

Furthermore, McKinsey & Company estimates that the cost of building a large-scale biopharmaceutical production plant ranges from USD 300 million to more than USD 500 million, depending on location, scale, and infrastructure needs. This significant initial investment is complex for smaller biopharmaceutical businesses with limited financial resources, as they may need more funds to construct and manage their manufacturing facilities.

Global Antibody Contract Manufacturing Market Opportunity

Expansion of the Biosimilar Market

With some blockbuster biologics patents expiring, the market for biosimilar antibodies is expected to rise. Biosimilars provide cost-effective alternatives to originator biologics, accelerating uptake in developed and emerging countries. Contract manufacturing organizations specializing in biosimilar development and manufacturing benefit from the growing biosimilar market by providing manufacturing services to firms looking to enter or extend their presence in this field.

With increased US acceptance, biosimilars are gaining traction. Successful businesses will reinvent their business models, rethink portfolio management, and accelerate R&D. For example, in December 2020, Amgen received FDA approval for its RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab), to treat adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. Furthermore, in May 2022, Health Canada approved Abevmy (Bevacizumab), a biosimilar to Roche's Avastin (Bevacizumab), for four cancer indications. 

Furthermore, the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have developed regulatory routes for biosimilar approval, creating a clear structure for biosimilar product development, appraisal, and approval. This regulatory assistance has hastened biosimilar development and commercialization, opening the potential for contract manufacturers to partner with biosimilar producers and provide manufacturing services.

Regional Analysis

The global antibody contract manufacturing market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global antibody contract manufacturing market shareholder and is estimated to grow at a CAGR of 12.8% over the forecast period. North America dominated the market in 2023, accounting for around 35%. This is due to the region's extensive biopharmaceutical manufacturing and the existence of a large number of CDMO/CMO facilities. State and other rules governing biologic development in the area are projected to impact biopharmaceutical contract manufacturing advancement substantially. In 2023, the United States accounted for approximately 90% of the North American market. Contributing factors include increasing clinical trials, key market competitors, a sophisticated healthcare system, rising demand for antibody contract manufacturing, and governments' increased attention to biologics. 

In addition, several mAb candidates for COVID-19 treatment have advanced to human clinical trials. They were made more broadly available to patients in months via fast-track approval or emergency use authorization. 

Asia-Pacific is anticipated to exhibit a CAGR of 12.9% over the forecast period. This growth can be ascribed to regulatory reforms, improved infrastructure, and the availability of many eligible study volunteers. Several biopharma businesses in the United States are exploring producing pharmaceutical goods in Asian countries due to rising R&D expenditures in their home market. Asian countries offer low-cost production facilities and workforce. The cost of production in Asian countries is 30 to 60% lower than in Western countries, fueling the antibody contract manufacturing business.

Since 2014, IMAPAC, the business behind Biologics Manufacturing Korea, has sponsored an academic conference in late February with 400 specialists from over 100 governments, non-governmental organizations, industry-related firms, and educational institutions. At this conference, great businesses are recognized and honored in each category. The conference covers various topics, including biologic drug development, manufacturing, quality assurance, and GMP and CMO operations. Many worldwide biopharmaceutical companies, CMOs, academia, and regulatory authorities from each country attend it.

Europe holds a moderate share of the market. In 2023, the United Kingdom accounted for around 25% of the European market. The burden of numerous infectious/neglected diseases and drug-resistant bacterial infections falls disproportionately on low-income countries. Hence, pharmaceutical companies need more financial motivation to undertake this research. 

Segmental Analysis

The global antibody contract manufacturing market is segmented based on product, source, and end-user.

The market is further segmented by product into Monoclonal Antibodies and polyclonal Antibodies.

Monoclonal antibody (mAb) formulations are becoming more popular as a targeted therapy for various lung conditions, including lung cancer, infections, and asthma. Casirivimab and imdevimab have also been shown to help treat COVID-19 infections; they are mainly designed to prevent the virus from attaching to and entering human cells. CMOs are increasingly partnering with biopharmaceutical businesses to produce and commercialize monoclonal antibodies. For example, WuXi Biologics cooperated with Vir Biotechnology, Inc. to produce sotrovimab antibodies for COVID-19 treatment. 

Furthermore, rising awareness among physicians and patients about the applicability of mAb treatment is driving additional growth. Moreover, mAb therapy will likely increase as blockbuster mAbs are approved for various indications during the projection period. Revenue-generating pharmaceuticals such as Remicade, Avastin, Herceptin, and Rituxan, which the FDA has approved for a variety of illnesses, including cancer, Crohn's disease, rheumatoid arthritis, ulcerative colitis, and others, help to expand the patient base. Thus, monoclonal antibodies held the most significant proportion in 2023.

Polyclonal antibodies are a collection of antibodies generated by various B cells in response to an antigen. Polyclonal antibodies identify numerous epitopes on an antigen, as opposed to monoclonal antibodies, which are generated from a single B cell clone. Polyclonal antibodies are often produced after immunizing animals with the target antigen, such as rabbits, mice, or goats. They are frequently employed in research, diagnosis, and therapy because of their capacity to detect a wide range of epitopes and antigens. Polyclonal antibodies are especially useful in applications that do not require excellent specificity, such as Western blotting, immunohistochemistry, and enzyme-linked immunosorbent tests (ELISA). In addition, they are frequently utilized as controls or standards in antibody-based assays to evaluate assay performance and accuracy.

Based on the source, the market is fragmented into Mammalian and Microbial.

The mammalian source segment held the highest market share as of 2023, accounting for 60%. With the increased demand for biopharmaceutical contract manufacturing services, several CMOs are increasing their capacity for mammalian cell culture manufacture. The mammalian cell expression method is the favored choice for mAb manufacturing due to the significant advantage of modifying the cellular mechanism for the processing, manufacture, and secretion of very complex molecules. 

Additionally, major companies are investing in increasing their mammalian cell expression system production capabilities. Several CMOs, like Lonza and Charles River, provide production services based on mammalian cell lines. These companies are making considerable expenditures to improve their mammalian cell culture manufacturing capabilities for antibody development. For example, WuXi Biologics has more than 150,000L of bioreactor capacity for mammalian cell culture supplies, which will be increased to 430,000L by 2023. 

Furthermore, new technologies for increasing mammalian expression system titers and yields are being developed. Companies like KBI Biopharma have implemented single-use process technology to improve mammalian manufacturing areas. A large percentage of biopharmaceutical compounds in development are mammalian expressed. With rising mammalian system titers and yields, facilities are working to homogenize their mammalian systems. This is expected to boost mammalian-based source market growth.

Microbial expression methods, such as Escherichia coli (E. coli) or yeast, are widely utilized for antibody synthesis, especially in research and diagnostic applications where cost-effectiveness and scalability are critical. Microbial systems provide benefits such as quick growth, high protein expression levels, and simple downstream processing, making them ideal for high-throughput antibody production. However, unlike mammalian-derived antibodies, microbial expression methods cannot undertake complicated post-translational modifications, resulting in protein structure and function variations. As a result, microbial-produced antibodies may have diminished biological activity or immunogenicity, making them unsuitable for therapeutic applications that need glycosylation patterns similar to those found in humans. 

The market can further bifurcate based on End-users into Biopharmaceutical Companies and Research Laboratories.

The biopharmaceutical firms section held the most significant share in 2023, accounting for more than 70%, and is also expected to increase the fastest during the projection period. The market is divided into three end-user categories: biopharmaceutical firms, research laboratories, and others. Biopharmaceutical businesses play an essential role in developing novel therapies for patients globally. 

In addition, the market is primarily driven by an aging population, rising chronic disease rates, and increased patient acceptance of novel and advanced therapies. Biopharmaceutical products' capacity to heal previously incurable illnesses has introduced novel pharmaceuticals. The continual need for innovation in treatment paradigms and the usage of advanced medicines such as monoclonal antibody therapy is driving up R&D expenditure in biopharmaceuticals. This, in turn, leads to collaboration between biopharmaceuticals and CMOs to develop innovative drugs, resulting in a significant share and influencing segment growth.

Academic institutions, government research organizations, and private research facilities that conduct basic and applied research in various scientific fields are all considered research laboratories. These laboratories use antibodies for different scientific purposes, including protein detection, cellular imaging, flow cytometry, and immunohistochemistry. Antibodies are critical tools in biomedical research, allowing scientists to investigate proteins' structure, function, and interactions in cells and tissues. Research laboratories frequently demand unique antibodies suited to their research needs, forcing them to seek antibody contract manufacturing services from specialized suppliers. Contract manufacturing companies provide custom antibody production services, enabling research facilities to obtain high-quality antibodies that fit their precise specifications and experimental needs. 

Recent Developments

• March 2024- Lonza signed an agreement to acquire Roche's large-scale biologics site in Vacaville (US).
• March 2024- Samsung Life Science Fund, which was founded by Samsung Biologics, Samsung Bioepis, and Samsung C&T and is managed by Samsung Ventures, and BrickBio, Inc., announced their investment in BrickBio, a preclinical-stage biopharmaceutical company focused on developing precision biologics using an expanded genetic code.